Pajjiż: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Botulinum toxin type A
Evolus Pharma B.V.
M03AX01
botulinum toxin type a
Other muscle relaxants, peripherally acting agents
Skin Aging
Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
Revision: 5
Authorised
2019-09-27
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER NUCEIVA 50 UNITS POWDER FOR SOLUTION FOR INJECTION botulinum toxin type A READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you have any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NUCEIVA is and what it is used for 2. What you need to know before NUCEIVA is used 3. How to use NUCEIVA 4. Possible side effects 5. How to store NUCEIVA 6. Contents of the pack and other information 1. WHAT NUCEIVA IS AND WHAT IT IS USED FOR NUCEIVA contains the active substance botulinum toxin type A. It prevents muscles from contracting, leading to a temporary paralysis. It works by blocking the nerve impulses to the muscles in which it has been injected. NUCEIVA is used for the temporary improvement in the appearance of vertical lines between the eyebrows. It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact. 2. WHAT YOU NEED TO KNOW BEFORE NUCEIVA IS USED _ _ NUCEIVA MUST NOT BE USED: - if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6); - if you have myasthenia gravis or Eaton Lambert syndrome (chronic diseases affecting the muscles); - if you have an infection or inflammation at the proposed injection sites. WARNINGS AND PRECAUTIONS Side effects possibly related to the spread of botulinum toxin from the site of injection can occur very rarely (e.g. muscle weakness, difficulty in swallowing or food or liquid entering the airways). Patients receiving recommended doses may have exag Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NUCEIVA 50 Units powder for solution for injection NUCEIVA 100 Units powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 Units botulinum toxin type A produced by _Clostridium botulinum._ Each vial contains 100 Units botulinum toxin type A produced by _Clostridium botulinum. _ _ _ After reconstitution each 0.1 mL of the solution contains 4 Units. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NUCEIVA should only be administered by physicians with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment. Posology The recommended injection per muscle site is 4 U/0.1 mL. Five injection sites (see Figure 1): 2 injections in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units. Botulinum toxin units are not interchangeable from one product to another. Doses recommended are different from other botulinum toxin preparations. In the absence of adverse reactions during the initial treatment, an additional course of treatment can be performed subject to a minimum interval of 3 months between the initial and repeat treatment. In the event of treatment failure (no visible improvement of glabellar lines at maximum frown) one month after the first course of treatment, the following approaches may be considered: • Examination of the causes of failure, e.g. inappropriate injection technique, incorrect muscles injected, and f Aqra d-dokument sħiħ